ClearFit

Basic Information

• Brand Name: ClearFit
• Primary DI: 90855113008084
• Version / Model: 171709
• Catalog Number: 171709
• Company Name: LONGEVITI NEURO SOLUTIONS LLC
• Labeler DUNS: 070659539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-09
• Public Version: 1
• Public Version Date: 2020-03-17
• Public Version Status: New
• Public Device Record Key: c5514932-f882-4242-b54e-e5782ca0f3ee

Device Description

Extra Small Flat

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	882.5330	2
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16131	Cranial resinous compound	A substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	90855113008084	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170410	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	37	Square centimeter